The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection

NCT04815226 | Unknown

• 1 other identifier: 2102-095-1198
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder.

Conditions

Neurogenic Bladder; Neurogenic Bowel; Spina Bifida; Fecal Incontinence; Fecal Impaction; Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• Change in nitrite and leukocyte esterase

  Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis

  Baseline

• Change in nitrite and leukocyte esterase

  Either complete or partial reduction of nitrite and leukocyte esterase on the

  4 weeks

• Change in nitrite and leukocyte esterase

  Either complete or partial reduction of nitrite and leukocyte esterase on the

  8 weeks

• Change in nitrite and leukocyte esterase

  Either complete or partial reduction of nitrite and leukocyte esterase on the

  12 weeks

Secondary Outcomes (3)

• Seoul Fecal Scoring

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Korean Neurogenic Bowel Dysfunction Score

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Safety efficacy of Peristeen Transanal Irrigation

  4 weeks, 8 weeks, 12 weeks

Study Arms (1)

Using Peristeen Transanal Irrigation

OTHER

All participants in the trial will use Peristeen Transanal Irrigation. Eligible volunteers will be those patients who have failed conventional supportive bowel care, have neurogenic bladder, and use CIC (ClC: Clean Intermittent Catheterization) daily.

Device: Peristeen Transanal Irrigation

Interventions

Peristeen Transanal Irrigation DEVICE

Using Peristeen Transanal Irrigation twice per week for 12 weeks

Using Peristeen Transanal Irrigation

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Between the ages, 5 to 18, and are diagnosed with neurogenic bladder.
• Use CIC (CIC: Clean Intermittent Catheterization) daily to empty the bladder.
• A recent history of fecal incontinence within the last 3 months
• More than two episodes of urinary tract infection and/ or pyuria within the last 6 months

You may not qualify if:

• An anatomical abnormality of the bladder neck.
• Known intractable origin of bacteriuria such as urolithiasis (kidney stone) or nonfunctional renal segment.
• Received bladder augmentation surgery
• Patient without completion of toilet training
• Either received following treatment diagnosed according to Peristeen® product safety guideline:
• Anorectal malformation
• Colorectal cancer
• Endoscopic polyp removal surgery in 3 months
• Ischemic colitis
• Acute inflammatory bowel disease
• Acute intestinal diverticulum.
• Radiotherapy to the colon
• Long-term corticosteroid usage

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Coloplast A/S: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Neurogenic Bowel; Spinal Dysraphism; Fecal Incontinence; Fecal Impaction; Urinary Incontinence

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Rectal Diseases; Intestinal Obstruction; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Kwanjin Park, M.D. Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 24, 2021
• Study Start: April 14, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)